After Bethesda (NIH Medical center) and Vancouver (BC Children Hospital), it will be tested for the first time in Europe at IRCCS Medea in Bosisio Parini (Lecco)
Cerebral palsy is the most common cause of childhood physical disability, affecting 2 in 1,000 live births. It is a group of developmental disorders of movement and posturedue to permanent damage that has occurred in the brain during the course of brain development of the fetus, newborn or infant.
Among the possible complications of infantile cerebral palsy are often the muscle contractures, followed by bone deformities. One of the most frequent manifestations is the so-called crouch gaiti.e. a squatting gait characterized by excessive flexion of the hip and knee. At the IRCCS Medea – Our Familyfor the first time in Europe, the experimentation of an intelligent robotic orthosis to improve the gait of children with infantile cerebral palsy begins.
The military origins of the device
The wearable exoskeleton is called Agilik and was developed by a small Canadian start-up, Bionic Power: it can assist or resist movement during walking, in order to facilitate knee extension. The history of the technology that underlies Agilik is curious. The forerunner, in fact, was born as a device to recover energy from passive motion of the knee helping the soldiers to recharge the batteries while driving (and therefore to be able to use more light ones). Soldiers from the Canadian, US and Israeli militaries had experienced this by marching through the jungles of Hawaii and the deserts of Israel to see how much energy this exoskeleton could muster.
In 2017, the National Institutes of Health Clinical Center (NIHCC) in Bethesda, Maryland (USA), has created a prototype exoskeleton for children with a squatting gait due to cerebral palsy. Since 2019, the startup has started research in collaboration with the Functional and Applied Biomechanics section of the Department of Rehabilitation Medicine at the NIHCC, for the development of intelligent wearable orthoses for children with cerebral palsy, spina bifida and muscular dystrophy.
Agilik an example of “serendipity”: from technology developed for the specific function of recharging the batteries by exploiting the passive movements of the knee, to a system for enhance and support the action of the quadriceps in children with cerebral palsy. I am thrilled that the first experimentation outside North America takes place in an Italian avant-garde reality as Astrolab says Walter EarningsCEO of Bionic Power Inc.
The clinical trial at Medea
Al Medea the instrument it will be tested in children with extension deficit due to infantile cerebral palsy, starting at 5 years of age. In particular, the researchers want to examine the functional, kinematic and muscle activation changes of the lower limb during walking with Agilik compared to walking without an exoskeleton. At Astrolab – the rehabilitation robotics laboratory of IRCCS Medea – we have advanced technologies for functional assessment and simulation of real contexts in which Agilik can be safely tested for pediatric patients, explains the Professor Giuseppe Andreonihead of the research area Technological innovations in rehabilitation of the Medea.
With him I will operationally follow the project the engineer Emilia Biffi: We will deal highly complex methodological and technological topics, for a structured validation of an innovation that could have an important clinical impact. More and more technologies are available to patients. it is essential for those who carry out research in the clinical field to rigorously verify the efficacy and safety of these technologies – explains the doctor Christine Maghini, physiatrist in charge of the Neuromotor Pathologies Operative Unit of the Medea —. Agilik could represent a assistive or rehabilitative solution for children with infantile cerebral palsy who have knee extension deficiency. This is precisely the objective of the trial at the start. The orthosis has already been tested in America, registered as a medical device with the FDA US (Food and Drugs Administration, USA), Health Canada and has the CE marking as a medical device in Europe.
Recruitment: free participation
The IRCCS Medea is actively recruiting participantsthat is children aged 5 to 17 with knee flexion problems due to infantile cerebral palsy. Participation is absolutely free, the commitment required a session of a couple of hours per week for 10 weeks. Children with infantile cerebral palsy often present also visual and auditory disturbances, eating and metabolic problems, intellectual disability, epilepsy, communication and behavior problems. Our Family is dedicated to the care and rehabilitation of children with disabilities or developmental disordersdealing with diagnosis, treatment, education and scholastic, social and occupational integration, through a global approach to the person and constant involvement of his family. In 28 rehabilitation centers (in Lombardy, Veneto, Friuli Venezia Giulia, Liguria, Campania, Puglia), they come every year treated more than 800 children and young people with PCI: of these, 49% cannot walk, use a wheelchair for travel, need physical assistance. More than half of the children who manage to develop independent walking still present severe difficulty moving long distances.
March 27, 2023 (change March 27, 2023 | 06:47)
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